ADVAITE CLIA Lab Receives Authorization to Offer COVID-19 SalivaDirect Test

ADVAITE announced the company's high complexity CLIA laboratory operating out of Chicago, IL has been authorized to offer Yale University's SalivaDirect™ test. SalivaDirect™ is a qualitative test for the detection of nucleic acid from SARS-CoV-2 in saliva collected without preservatives in a sterile container from individuals suspected of COVID-19 by their healthcare provider. SalivaDirect™ was developed by the Yale School of Public Health (YSPH) and has received an Emergency Use Authorization (EUA) from the United States Food and Drug Administration (FDA). The FDA limits the emergency use of SalivaDirect™ testing only to high-complexity CLIA-certified laboratories, such as ADVAITE's Chicago Laboratory, which have been formally designated as authorized laboratories by YSPH under the EUA 202097.

SalivaDirect™ provides analytical sensitivity of 99%, and specificity of 94%. The method has several unique differences compared to traditional PCR (polymerase chain reaction) methods, including (i) the use of saliva instead of the more invasive nasopharyngeal swab, and (ii) the lack of an additional nucleic acid extraction step, which can save valuable time when processing samples.

In a spring 2020 pilot program led by the Yale School of Public Health, the National Basketball Association (NBA), and the National Basketball Players Association (NBPA), SalivaDirect™ was successfully used to test asymptomatic people within the NBA and NBPA communities throughout the completion of the basketball season.

"The SalivaDirect COVID-19 PCR-based nucleic acid test will allow us to shift away from a defensive symptom-based strategy to a proactive surveillance-based strategy that enables communities and businesses to stay open safely during the pandemic," said Sandeep Jain M.D., Chief Scientific Officer & Co-Founder, ADVAITE Inc. "As an example of success of this strategy, mandatory saliva testing programs are currently being used in public universities to allow safe student and staff participation in campus housing, performing arts and athletics.”